SGI 110 gets oral dose of good news at ASH

" The dose escalation part of the study demonstrated that SGI-110 is well tolerated at doses higher than the biologically effective dose (BED); subcutaneous (SQ) administration achieved efficient conversion to decitabine resulting in an improved pharmacokinetic (PK) profile over intravenous (IV) Dacogen formulation; and clinical responses were observed in this heavily pretreated population which seem to correlate with the extent of LINE-1 hypomethylation.

"Following the preliminary presentation at AACR, this is the second oral presentation of clinical data for SGI-110 this year in which the full data set of the phase 1 part of the trial will be discussed. We are pleased with the progress of SGI-110 in the treatment of these difficult to treat hematological malignancies," said Mohammad Azab, MD, chief medical officer of Astex Pharmaceuticals."

"Conclusions: SGI-110 is well tolerated at doses higher than BED which is established at 60 mg/m2 dailyx5 where average hypomethylation of ~25% was achieved. MTD estimated to be 90 mg/m2 dailyx5 for MDS and 125 mg/m2dailyx5 for AML patients. SQ administration of SGI-110 achieved efficient conversion to decitabine resulting in an improved PK profile over DAC IV. Clinical responses were observed in this heavily pretreated population and they seem to correlate with the extent of LINE-1 hypomethylation. Study is currently enrolling patients in the dose-expansion Phase 2 stage.

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